(15 days)
The ClearVue 350/550 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in the following modes: B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Harmonics, iSCAN, X-Res, angio, 3D (freehand), and SonoCT. The system may also be used in biopsy guidance and to assist in infertility monitoring of follicle development (OB). The system is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications, as listed in FDA's Diagnostic Ultrasound Indications for Use Forms (included in the submittal):
Fetal / Obstetric
Abdominal
Pediatric
Small Organ (thyroid, scrotum, prostate, breast)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Musculoskeletal (conventional)
Musculoskeletal (superficial)
Other - Gynecological
Cardiac Adult
Cardiac Pediatric
Other - Fetal
Peripheral Vessel
Peripheral Vessel Other - Carotid
The clinical environments where the ClearVue 350/550 Diagnostic Ultrasound System can be used include hospital, clinical and medical office settings for diagnosis of patients. The use models for ClearVue 350/550 are within the scope of and substantially equivalent to current indications for use for Diagnostic Ultrasound System.
ClearVue 350/550 is a new general imaging or shared-service ultrasound system from Philips Ultrasound. The 550 model has more complete features than the 350, and an articulating arm for mounting of the display (the 350 has a tilt-swivel mount for the display). ClearVue provides excellent ultrasound capabilities in a lightweight, affordable system. Its intended use and indications for use are standard for general imaging and shared-service (general imaging + cardiac) systems, and are within the cleared intended use and indications for use for the Philips HD11 diagnostic ultrasound system (cleared in K043535), to which ClearVue is substantially equivalent.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the ClearVue 350/550 Diagnostic Ultrasound System:
Based on the provided text, the ClearVue 350/550 Diagnostic Ultrasound System is a general imaging or shared-service ultrasound system that is being submitted for substantial equivalence to an existing predicate device (Philips HD11 Diagnostic Ultrasound System, K043535).
The core of the submission argues that since the ClearVue 350/550 does not introduce any new indications for use, modes, features, or technologies compared to its predicate, no new clinical testing is required. Therefore, there isn't a dedicated clinical study in this submission that proves the device meets specific acceptance criteria in the way one might expect for a novel device or AI. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a device whose safety and effectiveness are already "well accepted."
Acceptance Criteria and Device Performance
Since no specific performance metrics for this device against new acceptance criteria are provided due to the nature of a substantial equivalence submission without new indications, the table below reflects the claim of equivalence to the predicate.
| Acceptance Criteria Category | Reported Device Performance (ClearVue 350/550) |
|---|---|
| Indications for Use | Matches predicate device (HD11) |
| Gray-scale capabilities | Same as predicate device (HD11) |
| Doppler capabilities | Same as predicate device (HD11) |
| Imaging Technologies | Essentially same as predicate device (HD11) |
| Doppler Functions | Essentially same as predicate device (HD11) |
| Signal Processing | Essentially same as predicate device (HD11) |
| Acoustic Output Levels | Below Track 3 FDA limits (same as predicate) |
| Manufacturing Quality | Equivalent quality systems as predicate |
| Bio-safety of Materials | Equivalent to predicate; safe for application |
| Electrical/Physical Safety Standards | Designed and manufactured to same standards as predicate |
Study Details (or lack thereof)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No new clinical test set was used for this submission. The device is deemed substantially equivalent based on non-clinical data and established safety/effectiveness of the predicate device.
- Data Provenance: Not applicable for a new clinical test set. The predicate device (HD11) would have had its own clinical data, which is implicitly relied upon.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new test set required ground truth establishment for this substantial equivalence submission.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a diagnostic ultrasound system, not an AI or CAD (Computer-Aided Detection) system requiring MRMC studies to assess human reader improvement.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a diagnostic ultrasound imaging system, not an algorithm in the sense of a standalone AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for this submission. The ground truth for the safety and effectiveness of the predicate device would have been established through methods appropriate for diagnostic ultrasound at the time of its clearance (K043535), which could include expert interpretation compared to clinical outcomes, pathology, or other established diagnostic methods.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable.
Summary of How the Device Meets Acceptance Criteria
The ClearVue 350/550 Diagnostic Ultrasound System meets its "acceptance criteria" by demonstrating substantial equivalence to a predicate device, the Philips HD11 Diagnostic Ultrasound System (K043535). The key arguments for this equivalence are:
- No new Indications for Use: The ClearVue 350/550 operates within the established indications already cleared for the HD11.
- Same Fundamental Scientific Technology: Both systems use the same core ultrasound technologies (gray-scale, Doppler, imaging, signal processing).
- Compliance with Standards: Non-clinical tests confirmed compliance with relevant international standards (e.g., IEC 60601 series, ISO 10993) for medical electrical equipment safety, electromagnetic compatibility, and biological evaluation, mirroring the predicate device's compliance.
- Equivalent Safety Profiles: Acoustic output levels, manufacturing quality systems, biosafety of materials, and electrical/physical safety standards are all stated to be equivalent to the predicate device.
Therefore, the "study" proving the device meets acceptance criteria is primarily a non-clinical comparison and declaration of adherence to existing standards and equivalence to a legally marketed predicate device, rather than a new clinical trial with specific performance metrics.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.